DEVICE: MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer (00081317002857)

Device Identifier (DI) Information

MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer
351-2700SZ
In Commercial Distribution
351-2700SZ
MENTOR TEXAS L.P.
00081317002857
GS1

1
167450993 *Terms of Use
Round Moderate Plus Profile Saline Breast Implant Sizer, 700cc
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Invasive breast implant sizer, single-use A sterile surgical instrument intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device is typically a balloon-like elastomer pouch with tubing that is placed in the pocket, filled to an optimal volume, and then removed. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MRD SIZER, MAMMARY, BREAST IMPLANT VOLUME
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010709 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

575d491d-f681-4655-b10c-38b863d78013
July 06, 2018
3
May 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)235-5731
xx@xx.xx
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